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Premarket Requirements for Nitric Oxide Delivery Systems and Gas Analyzers

This guidance document outlines requirements for premarket notification submissions for three types of devices: - Nitric Oxide Delivery Apparatus - Nitric Oxide Analyzer - Nitrogen Dioxide Analyzer These devices are used together as a system for delivering nitric oxide therapy to patients, while monitoring nitric oxide and nitrogen dioxide concentrations in the breathing circuit.

  1. Develop comprehensive test plan covering all performance, safety and EMC requirements
  2. Conduct design verification testing:
    • NO delivery accuracy
    • NO2 production
    • Analyzer accuracy
    • Environmental conditions
    • EMC/electrical safety
    • Endurance testing
  3. Prepare documentation package including:
    • Device description and specifications
    • Test reports and data
    • Software documentation
    • Risk analysis
    • Labeling
  4. Validate compatibility with specified ventilators
  5. Develop training materials and installation instructions
  6. Implement quality system controls for:
    • Design controls
    • Document control
    • Change management
    • Device master record
  7. Submit 510(k) with complete documentation package demonstrating compliance with all requirements
  8. Maintain post-market surveillance system to monitor device performance and safety

Key Considerations

Non-clinical testing

  • Testing must demonstrate accuracy and stability of NO delivery within 20% of set concentration
  • Testing must verify NO2 production is less than 1.0 ppm during administration of 40 ppm NO in 60% oxygen
  • Endurance testing required for 2000 hours with simulated use conditions
  • Testing must verify accuracy of NO and NO2 analyzers across specified ranges
  • Testing must demonstrate compatibility with specified ventilators

Human Factors

  • Controls must be protected from inadvertent changes
  • Controls must be clearly labeled and visible from 1 meter
  • Connectors must prevent incorrect connections
  • Device must minimize risk of patient strangulation from tubing/wires

Software

  • Software documentation required per FDA software guidance
  • Must include hazard analysis, verification and validation testing
  • Software version control required

Labelling

  • Must include prescription statement
  • Must specify validated ventilators
  • Must include installation instructions
  • Must include warning about required training
  • Must include specifications for accuracy and alarms
  • Must identify medical gas cylinder connections

Biocompatibility

  • Materials must be compatible with NO gas
  • Must minimize health risks from leached substances
  • Must verify material compatibility after endurance testing

Safety

  • Must include battery backup power if used with ventilators having backup power
  • Must include alarms for NO concentration, NO2 concentration, and power
  • Must prevent catastrophic release of NO
  • Must meet electrical safety requirements per IEC 601-1
  • Must meet EMC requirements per specified standards

Other considerations

  • IEC 601-1: Medical electrical equipment - Part 1: General requirements for safety
  • IEC 801-2: Electromagnetic compatibility for industrial-process measurement and control equipment
  • CISPR 11: Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics
  • MIL-STD-461D: Requirements for the control of electromagnetic interference emissions and susceptibility
  • ASTM F 1462-93: Standard Specification for Oxygen Analyzers
  • CGA C-9-1982: Standard Color Marking of Compressed Gas Containers for Medical Use

Original guidance

  • Premarket Requirements for Nitric Oxide Delivery Systems and Gas Analyzers
  • HTML / PDF
  • Issue date: 2000-01-24
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: fe8901033c6a0c7878283b0ddc6f8253
This post is licensed under CC BY 4.0 by the author.